Under the category of the OTC/Nutraceutical products are listed the products which are sold without prescription. Members of Farmavita.net are invited to publish their out-license offers in this Category.

Lamotrigine

Description

Farmavita:Net member offer transfer of marketing atuhorisation for Lamotrigine, tablets 25-50-100-200 mg, bulk supply with license for use of EU CTD Dossier. Registration is on-going in reference member state in EU.

Offer is valid subject to confirmation, country by country. Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.

INDICATIONS AND USAGE

Epilepsy

Adjunctive Use: Lamotrigine is indicated as adjunctive therapy for partial seizures in adults and pediatric patients (³2 years of age).

Lamotrigine is also indicated as adjunctive therapy for the generalized seizures of Lennox-Gastaut syndrome in adult and pediatric patients (³2 years of age).

Monotherapy Use: Lamotrigine is indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single EIAED.

Safety and effectiveness of Lamotrigine have not been established (1) as initial monotherapy, (2) for conversion to monotherapy from non enzyme-inducing AEDs (e.g., valproate), or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs

Safety and effectiveness in patients below the age of 16 other than those with partial seizures and the generalized seizures of Lennox-Gastaut syndrome have not been established.

Bipolar Disorder

Lamotrigine is indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.

The effectiveness of Lamotrigine as maintenance treatment was established in 2 placebo-controlled trials of 18 months duration in patients with Bipolar I Disorder as defined by DSM-IV. The physician who elects to use Lamotrigine for periods extending beyond 18 months should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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